Abstract
BackgroundAspirin is associated with gastrointestinal side effects such as gastric ulcers, gastric bleeding and dyspepsia. High-dose effervescent calcium carbasalate (ECC), a buffered formulation of aspirin, is associated with reduced gastric toxicity compared with plain aspirin in healthy volunteers, but at lower cardiovascular doses no beneficial effects were observed.AimTo compare the prevalence of self-reported gastrointestinal symptoms between low-dose plain aspirin and ECC.MethodsA total of 51,869 questionnaires were sent to a representative sample of the Dutch adult general population in December 2008. Questions about demographics, gastrointestinal symptoms in general and specific symptoms, comorbidity, and medication use including bioequivalent doses of ECC (100 mg) and plain aspirin (80 mg) were stated. We investigated the prevalence of self-reported gastrointestinal symptoms on ECC compared with plain aspirin using univariate and multivariate logistic regression analyses.ResultsA total of 16,715 questionnaires (32 %) were returned and eligible for analysis. Of these, 911 (5 %) respondents reported the use of plain aspirin, 633 (4 %) ECC and 15,171 reported using neither form of aspirin (91 %). The prevalence of self-reported gastrointestinal symptoms in general was higher in respondents using ECC (27.5 %) compared with plain aspirin (26.3 %), but did not differ significantly with either univariate (OR 1.06, 95 %CI 0.84–1.33), or multivariate analysis (aOR 1.08, 95 %CI 0.83–1.41). Also, none of the specific types of symptoms differed between the two aspirin formulations.ConclusionsIn this large cohort representative of the general Dutch population, low-dose ECC is not associated with a reduction in self-reported gastrointestinal symptoms compared with plain aspirin.Electronic supplementary materialThe online version of this article (doi:10.1007/s12471-014-0522-3) contains supplementary material, which is available to authorized users.
Highlights
Optimal antithrombotic therapy has proven to be essential in secondary prevention in cardiovascular disease
We investigated the prevalence of self-reported gastrointestinal symptoms on effervescent calcium carbasalate (ECC) compared with plain aspirin using univariate and multivariate logistic regression analyses
None of the specific types of symptoms differed between the two aspirin formulations. In this large cohort representative of the general Dutch population, low-dose ECC is not associated with a reduction in self-reported gastrointestinal symptoms compared with plain aspirin
Summary
Optimal antithrombotic therapy has proven to be essential in secondary prevention in cardiovascular disease. Different formulations of aspirin have been developed These formulations either delay the release of aspirin beyond the stomach (entericcoated aspirin), facilitate the transit of aspirin across the gastric mucous layer (PL2200), or increase solubility of aspirin supposedly resulting in lower irritating concentrations on the gastric mucosa (effervescent calcium carbasalate (ECC)). The gastric toxicity of different formulations was mainly studied in high dosages and showed clear benefit over plain aspirin with respect to gastric ulcer formation when studied in healthy volunteers [13,14,15,16,17,18]. Aspirin is associated with gastrointestinal side effects such as gastric ulcers, gastric bleeding and dyspepsia. High-dose effervescent calcium carbasalate (ECC), a buffered formulation of aspirin, is associated with reduced gastric toxicity compared with plain aspirin in healthy volunteers, but at lower cardiovascular doses no beneficial effects were observed.
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